Drug watchdog ponders how to open clinical trial data vault

ByTania Rabesandratana

ARTICLE ABSTRACT

The European Medicines Agency (EMA) is making good on a promise to become more transparent in an unprecedented way. By January 2014, it plans to introduce a broad new policy of public access to clinical trial data. Such sweeping glasnost doesn't appeal to the pharmaceutical industry, which is concerned that disclosing clinical study reports could open data to potential competitors. Others worry that without stringent safeguards, sensitive data about individual patients could end up in the wrong hands. EMA is discussing how to shape the new policy with academics, patient organizations, and drug companies; their final advice is due by the end of next month.